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Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02392351
Recruitment Status : Completed
First Posted : March 19, 2015
Results First Posted : October 4, 2019
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

Condition or disease Intervention/treatment Phase
Hypertension Device: Renal Denervation (Vessix) Device: Renal Angiography Not Applicable

Detailed Description:
Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE
Study Start Date : April 2015
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).
 Device: Renal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
Other Names:
  • Vessix Reduce™ Catheter and Vessix™ Generator
  • Vessix Renal Denervation System
Sham Comparator: Masked Procedure
Percutaneous renal angiography
 Device: Renal Angiography
Percutaneous renal angiography
Other Name: Renal Angiogram


Outcome Measures
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Primary Outcome Measures :
  1. OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks [ Time Frame: Through 8 weeks ]
    Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)


Secondary Outcome Measures :
  1. Number of Hospitalizations Due to Severe Hypotension/Syncope [ Time Frame: Through 6 months ]
    Number of hospitalizations due to severe hypotension/syncope through 6 months.

  2. Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it [ Time Frame: 4 weeks ]
    Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.

  3. Renal Artery Dissection or Perforation Requiring Intervention [ Time Frame: 4 weeks ]
    Number of renal artery dissection or perforation requiring intervention through 4 weeks.

  4. Vascular Complications [ Time Frame: 4 weeks ]
    Number of vascular complications through 4 weeks.

  5. Significant New Renal Artery Stenosis [ Time Frame: 6 months ]
    Number of significant new renal artery stenosis events through 6 months.

  6. Number of Subjects Utilizing Anti-hypertensive Medications [ Time Frame: 3 months ]
    Number of subjects utilizing anti-hypertensive medications at 3 months.

  7. Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months [ Time Frame: 6 Months ]
    Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline

  8. Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months [ Time Frame: 6 Months ]
    Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.

  9. Number of Subjects Utilizing Anti-hypertensive Medications [ Time Frame: 6 months ]
    Number of subjects utilizing anti-hypertensive medications at 6 months

  10. Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure [ Time Frame: 12 Months ]
    Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months

  11. Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure [ Time Frame: 12 Months ]
    Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months

  12. All-Cause Death [ Time Frame: 24 Months ]
    Number of all causes of death through 24 months

  13. Number of Participants With Renal Failure [ Time Frame: 24 Months ]
    Number of renal failure events through 24 months

  14. Number of Participants With Hypertensive Crisis [ Time Frame: 24 Months ]
    Number of hypertensive crisis events through 24 months

  15. Mean Reduction in Average Office-based Systolic Blood Pressure [ Time Frame: 24 Months ]
    Mean Reduction in Average office-based systolic blood pressure through 24 months

  16. Mean Reduction in Average Office-based Diastolic Blood Pressure [ Time Frame: 24 Months ]
    Mean Reduction in Office-based diastolic blood pressure through 24 months

  17. Percent of Subjects at Target Blood Pressure [ Time Frame: 24 Months ]
    Percent of subjects at target blood pressure through 24 months

  18. Congestive Heart Failure [ Time Frame: 24 Months ]
    Number of subjects with congestive heart failure through 24 months

  19. Myocardial Infarction [ Time Frame: 24 Months ]
    Number of subjects who experience myocardial infarction through 24 months

  20. Stroke [ Time Frame: 24 Months ]
    Number of subjects experiencing stroke through 24 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 and ≤75 years
  • OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements
  • Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg
  • For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
  • Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent

Exclusion Criteria:

  • Stenosis >30% or renal artery aneurysm in either renal artery
  • Fibromuscular dysplasia (FMD)
  • Known causes of secondary HTN
  • Type 1 diabetes mellitus
  • eGFR <40 mL/min/1.73m2
  • Known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months
  • Severe valvular heart disease
  • ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392351


Locations
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United States, Alabama
Cardiology, PC
Birmingham, Alabama, United States, 35211
United States, California
Cedars - Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
United States, Texas
Dallas Medical Center
Dallas, Texas, United States, 75006
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
United States, Wisconsin
Aspirus Heart and Vascular Institute
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Martin B Leon, MD Columbia University
Principal Investigator: Michael Weber, MD SUNY Downstate College of Medicine
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] January 23, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02392351    
Other Study ID Numbers: S2333
First Posted: March 19, 2015    Key Record Dates
Results First Posted: October 4, 2019
Last Update Posted: February 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Boston Scientific Corporation:
Hypertension
Renal Denervation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases